Events

Recall of Peritoneal Lavage Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29819
  • Event Risk Class
    Class 2
  • Event Number
    Z-1408-04
  • Event Initiated Date
    2004-08-02
  • Event Date Posted
    2004-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34583
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, Peritoneal - Product Code GBW
  • Reason
    Wrong introducer needle in some kits.
  • Action
    The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.

Device

Peritoneal Lavage Kits
  • Model / Serial
    Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
  • Product Description
    Peritoneal Lavage Kits, Model number AK-09000
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA